Millions of children, adults and infants in less developed nations are born into and live in an environment that is extremely unsanitary. Even in urban areas, roads in low income neighborhoods are frequently unpaved and fecal material from humans and animals is in the air and water storage tanks. Many households have no sanitary latrine facilities. Electricity is frequently unavailable and when it is, families often cannot afford a refrigerator. Households must frequently fetch water from community water faucets at substantial distances. In some communities, there is no piped water at all and residents must rely on tanker trucks to fill drums located outside their shacks. These outside water storage drums are exposed to dirt, dust and many forms of bacteria.
Many families cannot afford the fuel needed to boil drinking water. Thus, unboiled, contaminated water is often used to prepare family meals, infant formula or other baby food. Consequently, the food becomes a vehicle for pathogenic bacteria to colonize the adult, child or infant gut increasing the risk of diarrhea and other disease. If the water is boiled but the prepared food or infant formula remains unrefrigerated for several hours before consumption, it can be colonized by bacteria prior to its consumption.
Pathogenic challenges to the gastrointestinal (GI) tracts of infants, young children and adults, particularly aged adults in low income families in less developed nations are frequent and intense.
The human infant has an immature immune system which does not become fully functional until 6-20 months of age. This deficit is biologically compensated for by the fact that human breast milk provides immunity in the form of antibodies, macrophages, complement and a whole host of other immunological factors that assist the infant GI tract in coping with viral and bacterial hazards in the environment. Human milk also contains lysozyme, a bactericidal enzyme active in the infant GI tract. In addition to protecting the GI tract from infection, human milk also often contains antibodies to systemic (non-GI tract) infections such as respiratory rotaviruses, poliomyelitis and measles.
In addition to antibacterial and antiviral factors, human milk has a chemical, which has been termed the "bifidus factor", which stimulates the intestinal growth of the protective bifidus bacteria, at the expense of competing bacteria, many of which are pathogenic. The bifidus bacteria is a benign microorganism and when it becomes a principal inhabitant of the colon, pathogens are less able to multiply rapidly enough to cause disease.
It has been shown that the greater the frequency of breast feeding, the greater the protection from diarrheal disease. Infants who receive infrequent daily breast feedings, have little protection from such disease compared to infants who receive ad lib breast milk. The bifidus factor as well as the immunity in human milk both play a role in this protective process.
Many efforts are underway around the world to encourage exclusive breast feeding. However, the realities of economic life often mitigate against this, even for those women who would prefer to exclusively breast feed. In the absence of workplace day care, working women in rich and poor countries alike find it virtually impossible to exclusively breast feed.
To date, no simple remedy has been found that could effectively prevent diarrhea in both young children and non-exclusively breast fed infants in the less developed nations. Improved sanitation and hygiene, while desirable from a public health standpoint, are often economically unfeasible in poor nations, particularly given the very rapid growth of squatter communities in large urban centers throughout the developing world.
In addition to young children and infants, adults frequently encounter diarrhea, and the problem may be particularly dangerous for aged adults. Although adults have a more developed immune system more capable of protecting the host from pathogenic attacks, immuno-compromised adults, and even healthy adults, are frequently subjected to attacks of diarrhea due principally to the ingestion of contaminated water or food.
Even short periods of diarrhea significantly alter the intestinal absorption of ingested food and liquids in adults, threatening the health of the adult. At the very least, acute diarrhea is a troubling and inconvenient illness. Persistent and chronic diarrhea are more dangerous, since these conditions often result in malnutrition and an increasingly weakened immune system, permitting the host to be invaded by other opportunistic infections. With the elderly as well as young children and infants, diarrhea can be life threatening.
Diarrhea is also expensive to nations and families. The cost of treating diarrhea at a children's hospital (Hospital Infantil Federico Gomez) in Mexico City was recently investigated and it was found that 11% of emergency outpatients and 7.5% of inpatients were diagnosed as having diarrhea.
Caramels are confectionery products obtained by heating glucose, sucrose or other reducing sugars. The time generally required to achieve caramelization is several hours, typically from 3 to 9 hours. The composition of caramels has been studied previously and caramels prepared from sucrose have been shown to contain small amounts of oligosaccharides, predominantly glucose disaccharides.
Recently, a new type of caramel containing a high content of fructose oligosaccharides, termed sucrose thermal oligosaccharides (STO), has been prepared and is described in U.S. patent application No. 07/983,446 filed Dec. 12, 1992, which is hereby incorporated by reference in its entirety.
The sucrose thermal oligosaccharide (STO) caramel of U.S. patent application No. 07/983,446 is prepared by milling sucrose and an organic acid in a ball mill for approximately 0.5 to 4 hours, heating to a temperature of 130.degree.-160.degree. C. for 0.5 to 15 minutes and cooling quickly to produce the sucrose thermal oligosaccharide (STO) caramel product. The caramel contains an unusually high content of fructose oligosaccharides.
Further, two new types of sugar compositions have been recently prepared by the thermolysis of amorphous sucrose under selected conditions for each reaction. In one aspect, kestoses containing fructose moieties are produced by the thermal reaction of amorphous sucrose in the presence of an acid catalyst at a temperature of 80.degree. to 100.degree. C. The product comprises a mixture of sucrose thermal kestoses. In a second aspect, amorphous sucrose is polymerized in admixture with an acid catalyst at temperatures of 125.degree.-175.degree. C. to produce a fructoglucan polymer. The process and final products are set forth in U.S. Pat. No. 5,206,355 issued Apr. 27, 1993, which is hereby incorporated by reference in its entirety.
According to the present invention it has been unexpectedly discovered that STO caramels prepared according to U.S. application Ser. No. 07/983,446 and sucrose thermal kestoses and fructoglucan polymers prepared according to U.S. Pat. No. 5,206,355, significantly prevent the occurrence and reoccurrence of diarrhea in humans.